Immunomodulatory effects of Inulin-type fructans in a hepatitis B vaccination study
Completed
- Conditions
- vaccination efficacy in healthy individualsvaccination efficacyvaccine-specific antibody response
- Registration Number
- NL-OMON41596
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
Inclusion Criteria
Age 18-35 yr.
Healthy subjects
Male and female subjects
Caucasian subjects
Subjects enrolled to be vaccinated against Hepatitis B
Written informed consent
Dutch speaking subjects, i.e. subjects understanding spoken and written Dutch language
Exclusion Criteria
Presence of acute or chronic diseases
Gastrointestinal disorders (e.g. inflammatory bowel disease, celiac disease)
Gastrointestinal surgery
Treatment with antibiotics within 6 months of the start of the study
Prior vaccination with hepatitis B
Previous hepatitis B infection
Immunodeficiencies
Use of anti-coagulant drugs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Hepatitis B vaccine-specific antibody titers:<br /><br>Blood samples of 10 mL per timepoint of all subjects will be taken at day 21<br /><br>and 35 of the study, for measuring antibody titers by ELISA hepatitis B<br /><br>antibody-specific microtiter plates. </p><br>
- Secondary Outcome Measures
Name Time Method